(170 days)
Not Found
No
The document describes contact lenses and their material properties, intended use, and performance testing. There is no mention of AI or ML technology being used in the device itself or in its manufacturing process as described in this summary.
No
The device is indicated for optical correction of refractive errors (myopia, hyperopia, astigmatism, presbyopia), not for treating or curing a medical condition.
No
Explanation: The device is a contact lens intended for optical correction of refractive errors, not for diagnosing medical conditions.
No
The device description clearly states that the device is a soft contact lens made of a specific material (nelfilcon A) and is supplied as a physical product in blister packs. This indicates it is a hardware medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia) in the eye. This is a direct therapeutic or corrective function, not a diagnostic one.
- Device Description: The device is described as a soft contact lens made of a specific material, designed to sit on the eye for vision correction.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, collect a sample from the body for analysis, or provide information about a patient's health status through in vitro testing.
- Anatomical Site: The device is applied to the eye, which is an in vivo application, not an in vitro (outside the body) application.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This contact lens does not perform any such function.
N/A
Intended Use / Indications for Use
DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
DAILIES AquaComfort Plus FreshTech (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
Dailies AquaComfort Plus Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 6.00 diopters (D) of astigmatism.
Dailies AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of presbyopia with or without refractive ametropia) in phakic or aphakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.
DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. the lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
Product codes
LPL, MVN
Device Description
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal are soft contact lenses intended for the optical correction of refractive error.
They are available in spherical, toric and multifocal designs as applicable:
- Spherical lenses: DAILIES AquaComfort Plus
- Aspherical lenses: DAILIES AquaComfort Plus FreshTech
- o Toric lenses: DAILIES AquaComfort Plus Toric
- Multifocal lenses: DAILIES AquaComfort Plus Multifocal 0
The lens material is nelfilcon A, a high water non-ionic hydrophilic lens material consisting of approximately 31% PVA (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide) and 69% water. The material further contains non-functionalized PVA (high- and or Ultra molecular weight PVA) and the color additive phthalocyanine green (CFR 73.3124).
DAILIES AquaComfort Plus products are supplied sterile. The lenses are immersed in buffered saline solution and are packaged in individual foil-blister packs as primary packaging and terminally sterilized in a validated autoclave (moist heat, steam under pressure). The blister pack primary packaging system consists of an injection molded polypropylene blister shell sealed with a polyester coated aluminum foil lidding material. The lenses are supplied in strips of five foiled sealed blister packs each containing approximately 0.65 ml of phosphate-acetate buffered saline solution. The packaging saline may contain up to 0.05% Poloxamer 108. The package saline additionally contains the comfort additives hydroxypropylmethyl cellulose (HPMC) and polyethyleneglycol 400 (PEG 400). Sealed blister strips are provided in secondary packaging carton boxes containing 5, 30 or 90 lenses each.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was performed in accordance with the May 1994 FDA guideline, Premarket Notification 510(k) Guidance Document for Class II Contact Lenses and applicable ISO standards for contact lenses. Performance data are provided in support of the substantial equivalence determination.
Biocompatibility Testing: Test results from a series of in vitro and in vivo biocompatibility evaluations, including cytotoxicity, ocular irritation and systemic toxicity testing confirm that the minor device modification does not negatively impact the safety of the devices. The modified device is non-toxic and biocompatible. All biocompatibility testing was conducted in accordance with the GLP regulation (21 CFR Part 58) and relevant ISO 10993 series biocompatibility standards.
Sterilization: Based on the similarity of the packaging materials and the successful completion of sterilization testing in accordance with FDA guidance and the applicable requirements of ISO 17665-1:2006.
Stability Testing: Successful stability testing supports the labeled expiration date for the modified device.
Clinical Testing: Based on the similarity of the modified device to the predicate device and successful results of nonclinical testing, clinical testing was not required to establish substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K963487, K072777, K172066, K180398
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
Alcon Laboratories, Inc. Katryna Warren Global Project Regulatory Director, Vision Care 6201 South Freeway Fort Worth, TX 76134-2099
Re: K181454
Trade/Device Name: DAILIES® AquaComfort Plus®, DAILIES® AquaComfort Plus® FreshTech, DAILIES® AquaComfort Plus® Toric, DAILIES® AquaComfort Plus® Multifocal Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: October 22, 2018 Received: October 23, 2018
Dear Katryna Warren:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting of medical devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely yours,
J. Angelo Green
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Alcon Response to KDA Deireiency Letter DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K181454
Device Name
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal
Indications for Use (Describe)
DAILIES AquaComfort Plus (nelficion A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
DAILIES AquaComfort Plus FreshTech (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
Dailies AquaComfort Plus Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 6.00 diopters (D) of astigmatism.
Dailies AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of presbyopia with or without refractive ametropia) in phakic or aphakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.
DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. the lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
| Type of Use ( Select one or both, as applicable ) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
This 510(k) summary document has been prepared in accordance with section 21 CFR 807.92.
I. Submitter of the 510(k)
| Company: | Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099, USA |
|-------------------------|----------------------------------------------------------------------------------|
| Primary Contact Person: | Katryna Warren
Global Project Regulatory Director, Vision Care |
| Phone: | (817) 615-5076 |
| Fax: | (817) 551-4630 |
| Email: | Katryna.warren@alcon.com |
| Back up Contact Person: | Sherri Lakota
Head, GRA Alcon Vision Care |
| Phone: | (817) 615-5472 |
| Fax: | (817) 551-4630 |
| Email: | Sherri.lakota@alcon.com |
| Date Prepared: | May 30, 2018 |
II. Devices Subject to this 510(k)
| Trade Names: | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus
FreshTech, DAILIES AquaComfort Plus Toric and DAILIES
AquaComfort Plus Multifocal |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Soft Contact Lenses |
| Classification Name: | Soft (hydrophilic) Contact Lens |
| Device Classification: | Class II [21 CFR 886.5925] |
| Product Code: | MVN, LPL |
4
III. Predicate Device
The 510(k) devices are modifications of the same predicate devices currently legally commercialized devices cleared in the US under these 510(k) clearances: K963487, K072777, K172066, and K180398.
IV. Device Description
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal are soft contact lenses intended for the optical correction of refractive error.
They are available in spherical, toric and multifocal designs as applicable:
- Spherical lenses: DAILIES AquaComfort Plus ●
- Aspherical lenses: DAILIES AquaComfort Plus FreshTech ●
- o Toric lenses: DAILIES AquaComfort Plus Toric
- Multifocal lenses: DAILIES AquaComfort Plus Multifocal 0
The lens material is nelfilcon A, a high water non-ionic hydrophilic lens material consisting of approximately 31% PVA (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide) and 69% water. The material further contains non-functionalized PVA (high- and or Ultra molecular weight PVA) and the color additive phthalocyanine green (CFR 73.3124).
DAILIES AquaComfort Plus products are supplied sterile. The lenses are immersed in buffered saline solution and are packaged in individual foil-blister packs as primary packaging and terminally sterilized in a validated autoclave (moist heat, steam under pressure). The blister pack primary packaging system consists of an injection molded polypropylene blister shell sealed with a polyester coated aluminum foil lidding material. The lenses are supplied in strips of five foiled sealed blister packs each containing approximately 0.65 ml of phosphate-acetate buffered saline solution. The packaging saline may contain up to 0.05% Poloxamer 108. The package saline additionally contains the comfort additives hydroxypropylmethyl cellulose (HMPC) and polyethyleneglycol 400 (PEG 400). Sealed blister strips are provided in secondary packaging carton boxes containing 5, 30 or 90 lenses each.
5
v. Indications for Use
DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
DAILIES AquaComfort Plus FreshTech (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in notaphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
DAILIES AquaComfort Plus Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 6.00 diopters (D) of astigmatism.
DAILIES AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of presbyopia, with or without refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) of astigmatism that does not interfere with visual acuity.
DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
VI. Comparison to Technological Characteristics with the Predicate Device Table 1 summarizes the characteristics of the modified device compared to the predict devices:
| Element of Comparison | Predicates Devices | Modified Device |
|---|---|---|
| Administrative/ Regulatory Information | ||
| 510(k) Number | K963487, K072777, K172066, | |
| K180398 | To be assigned | |
| Product Name | DAILIES AquaComfort Plus, | |
| DAILIES AquaComfort Plus | ||
| Toric, DAILIES AquaComfort | ||
| Plus Multifocal | DAILIES AquaComfort Plus | |
| FreshTech |
6
| Device Classification
Information | Class II, Daily Wear Soft
(Hydrophilic) Contact Lenses | Same |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Indications for Use Information | | |
| Intended Use | One-Day contact lenses for the
optical correction of vision.
Single use, daily disposable
wear | Same |
| Technology Information | | |
| Lens Material | nelfilcon A | Same |
| Water Content | 69% | Same |
| Visibility Tint | Light blue (copper
phthalocyanine blue | Same |
| Manufacturing Method | Lightstream Technology: Full
mold cast | Same |
| Lens Design | Spherical, Toric, Multifocal | Aspheric |
| Sterilization | Steam sterilization, validated
autoclave | Same |
| Primary Packaging System in
General | Foil blister pack container
system; Polypropylene blister
shell sealed with a polyester
coated aluminum foil lidding | Same |
| Primary Packaging Blister
Shell | Injection-molded polypropylene
blister shell made from Flint
Hills Resources P4C5N-046
Polypropylene or Formosa
4142T polypropylene | Same |
| Primary Packaging Foil
Lidding | Multilayer laminate structure
polyester coated aluminum foil
lidding supplied by Constantia-
Hueck Folien
and/or Huhtamaki foil | Same |
| Package Storage/Saline
Solution | Phosphate-acetate buffered
saline with up to 0.05%
Poloxamer 108. Additionally
contains PEG and HPMC | Same |
| Performance Specifications
Including any Testing | | |
| Refractive Index | 1.38 (hydrated) | Same |
| Light Transmittance | ≥ 92%T @ 610 nm | Same |
| Oxygen Permeability (Dk) | $26 x 10^{-11} (cm^2/s) ml O_2/ml x mmHg)$ measured at 35°C (Fatt,
edge effect corrected) | Same |
| Elastic Modulus | 0.9 MPa | Same |
| Biocompatibility | Biocompatible as confirmed by
appropriate biocompatibility
testing | Same |
| Shelf-life | Up to 60 months as confirmed
by shelf-life stability testing | Same |
In accordance with the criteria for claims of substantial equivalence in the FDA guidance Premarket Notification 510(k) Guidance Document for Daily Wear contact Lenses, May 1994,
7
the information provided supports the claim of substantial equivalence to a lens with an existing USAN and the same manufacturing process.
VII. Performance Data
Performance testing was performed in accordance with the May 1994 FDA guideline, Premarket Notification 510(k) Guidance Document for Class II Contact Lenses and applicable ISO standards for contact lenses. Performance data are provided in support of the substantial equivalence determination.
Biocompatibility Testing
Test results from a series of in vitro and in vivo biocompatibility evaluations, including cytotoxicity, ocular irritation and systemic toxicity testing confirm that the minor device modification does not negatively impact the safety of the devices. The modified device is non-toxic and biocompatible. All biocompatibility testing was conducted in accordance with the GLP regulation (21 CFR Part 58) and relevant ISO 10993 series biocompatibility standards.
Sterilization
Based on the similarity of the packaging materials and the successful completion of sterilization testing in accordance with FDA guidance and the applicable requirements of ISO 17665-1:2006
Stability Testing
Successful stability testing supports the labeled expiration date for the modified device.
Clinical Testing
Based on the similarity of the modified device to the predicate device and successful results of nonclinical testing, clinical testing was not required to establish substantial equivalence.
VIII. Conclusions
The results of device performance testing evaluation including physico-chemical, biocompatibility, sterilization and stability and the qualification of the dimensional and optical properties demonstrate that the aspheric lens design meets specifications. The results supports the substantial equivalence of the device to the predicate device.